S1R Imaging-Based Cryoneurolysis in Chronic Pain

Molecular Imaging-Based Cryoneurolysis: Targeting Upregulated Sigma-1 Receptor Positive Nerves in Chronic Pain

Status

Not yet recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07768501

Enrollment

Registered

2026-08-17

Start date

2026-09-01

Completion date

2030-09-01

Last updated

2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Mixed Pain (Nociceptive and Neuropathic)

Keywords

chronic pain, PET/MRI, cryoneurolysis

Brief summary

The goal of this clinical trial is to determine whether a sigma-1 receptor PET/MRI scan can help identify the specific nerves responsible for chronic pain. Researchers will use an investigational imaging agent called \[18F\]FTC-146 to look for signs of pain generating nerve irritation or injury that may not be visible on convention imaging tests. Participants whose pain-generating nerve can be identified may undergo a diagnostic nerve block and, if successful, a standard clinical procedure called cryoneurolysis will be used to temporarily interrupt pain signals.

Interventions

DRUG[18F]-FTC-146

Participants will receive a single intravenous injection of up to 5-10 mCi of \[18F\] FTC-146 inside the PET/MRI scanner. They will undergo up to three (3) whole-body PET/MRI scans with possible additional focused scan of the painful area within 180 minutes post- injection.

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Chronic nociceptive, neuropathic, or mixed pain for ≥2 months 2. Pain originating from a region amenable to cryoneurolysis (celiac plexus, intercostal nerves, pudendal nerve, peripheral nerve block 3. Chronic pain ≥2 months 4. Pain score ≥4/10 5. Pain location amenable to cryoneurolysis 6. Willing and able to provide consent.

Exclusion criteria

1. Pregnancy or nursing. 2. Non-English speaking individuals 3. Contraindication to MRI scanning which includes, but is not limited to, incompatible metal or hardware including pacemakers, cochlear implants, and bullets near a critical organ. 4. Weight \>350 pounds or a large body habitus, which the MR scanner cannot accommodate. 5. Claustrophobia or feeling that he or she will be unable to lie still in the scanner for a period of 2 hours or fit in the PET/MR scanner due to body size.

Design outcomes

Primary

Measure	Time frame	Description
Pain Scores and Functional Interference (Pain Disability Index [PDI])	Assessed at baseline (pre-procedure) and at 1, 3, 6, and 12 months following cryoneurolysis.	The Pain Score measures pain intensity on a numeric or visual scale, from 0 to 10. The Pain Disability Index (PDI) measures how much pain limits a person's daily life across seven functional areas, scoring impact from 0 to 10 for each category.

Secondary

Measure	Time frame	Description
Pain medication	1, 3, 6, 12 months	Change in overall pain medication usage pre and post intervention. Opioids will be measured in oral morphine equivalents
Imaging Correlation	At time of imaging and clinical assessment prior to intervention	Degree of overlap between S1R focal uptake and clinical dermatomal pain diagrams. Correlation of SUVmax with pain severity.
Procedural Correlation	at 1 month post procedure	Degree of overlap between S1R treated focal uptake and clinical outcomes

Contacts

PRINCIPAL_INVESTIGATORLynne N Martin, MD

Stanford School of Medicine, Radiology

PRINCIPAL_INVESTIGATORKip E Guja, MD, PhD